The dosing device for delivering a medicinal agent for treating the glucose metabolic disorder to a body is an injection device or an inhalation device, preferably a device for delivering or injecting insulin. Such devices are known, for example, as an insulin pen (for example, from Novo Nordisk Inc. and Johnson & Johnson, Inc.), an insulin pump (for example, from Roche Diagnostics GmbH), or insulin inhalers. Insulin pens are thick sticks having a needle and an insulin cartridge for delivering multiple doses of insulin, whereby a new piercing occurs each time. The number of units of insulin to be delivered upon a piercing is set by a setting wheel. Insulin pen injection devices having an integrated time standard are known from U.S. Pat. No. 5,925,021 and DE 695 34 225.
An insulin pump is a medical device for continuous or interval-type subcutaneous insulin infusion. It is a small infusion device which is worn on the body and supplies insulin to the body continuously or at intervals via a catheter and a needle lying below the skin. The dosing may also be adapted to a specific daily routine or specific events, such as before or after a meal.
A blood glucose measuring device is an analytical measuring device for determining or recording (so-called “electronic diary”) a blood glucose value. Such devices are also referred to as blood glucose meters, blood sugar measuring devices, or blood glucose recorders. Blood glucose recorders are devices which record blood glucose concentrations over a predefined period of time, for example, to be able to establish a suitable insulin dosing scheme for a diabetes patient.
A blood glucose measuring device is a device which may determine the blood sugar content. For this purpose, a piercing wound is typically generated in a body, a blood droplet is taken, and the blood glucose content in the droplet is determined with the aid of the blood sugar measuring device. However, it is also conceivable to measure the blood glucose by a permanent measurement, for example, using sensors inserted into the body or by measuring through the skin.
Dosing devices and blood glucose measuring devices are capable of functioning and operating independently, i.e., independently of other connected components or devices. For example, a measuring device delivers measured values or an insulin pump operates without being connected to another device. It also has a separate internal power supply in this case and is operable line-independent.
A data processing apparatus may, for example, be a PDA, a data manager, a communication adapter (see EP 1 762 955), or a PC, which is used to read, store, or display stored data from the dosing device and blood glucose measuring device.
The dosing device in exemplary embodiments comprises an integrated time counter for generating relative time values, a memory unit in which data sets of dosing quantities and associated time values are stored, and a device for transmitting stored data sets to a data processing apparatus. The blood glucose measuring device for determining the blood glucose content of the body comprises an integrated time standard (e.g., a clock), a memory unit in which data sets of blood glucose measurements and associated time values are stored, and a device for transmitting stored data sets to a data processing apparatus. The device for transmitting the data sets may be integrated in the blood glucose measuring device, connected as a separate module thereto, or integrated in the data processing apparatus.
Dosing data from the dosing device and analysis results from the blood glucose measuring device are transmitted together with associated time values from the time counters of the dosing device and blood glucose measuring device to the data processing apparatus and processed therein. The time values are converted into corrected time values by comparing the time values with the time standard. The term “associated time values” means the particular time values at which the associated dosing or analysis occurred are transmitted.
A plurality of portable devices for measuring the blood sugar level is known in the prior art, in which a blood sample is dispensed onto a test element, which is subsequently analyzed using the blood glucose measuring device. Blood glucose measuring devices of this type typically have a memory, in which analysis results and the corresponding time at which the measurements were performed are stored. Furthermore, there are systems in the prior art in which the analysis results of a blood glucose measuring device are relayed or transmitted to an analysis unit. Devices of this type are becoming increasingly more significant in particular in the care and education of diabetics. The diabetic may solely decide whether insulin must be injected on the basis of individual measurements. In contrast, through the acquisition of blood sugar measurements over the course of a day and during multiple days or weeks, the diabetic may obtain information about how his blood sugar level is influenced by ingestion of food, physical activities, and other factors. In addition, the diabetic receives important information about how his body responds to the delivery of insulin by a history of monitoring the blood sugar level.
A diabetes data management system is commercially available from Roche Diagnostics GmbH. The data obtained using a handy blood sugar measuring device is transmitted in this system to a PC, which displays the history of the blood sugar level over time and also allows analyses which provide the patient with indications of the strength of the above-mentioned influencing factors. Systems which provide historical monitoring of the blood sugar level are designed in such a manner that the user first performs a plurality of measurements and transmits the measurement results to an analysis unit at a later point in time. It is therefore necessary to also store the times at which the analyses were performed together with the results in the blood glucose measuring device.
Because both dosing devices and blood glucose measuring devices must operate reliably over a period of time of months or years, it is necessary to either install a clock having a high running precision in the device or to provide a clock that may be set. On the one hand, clocks having high running precision with changing ambient temperatures are still relatively expensive. On the other hand, it is inconvenient for the user to have to set the clock. In addition, setting the clock requires additional operating elements which must be integrated into the device and thus makes it more costly. Moreover, it is also undesirable in many cases that the diabetic can adjust the clock. Specifically, historical monitoring is frequently performed to check whether the diabetic follows the rules and/or instructions provided by the physician. A further aspect are time changes, for example, between summer and winter and upon the change between time zones. Adjusting the clock to the current time may result in the later assignment or adjustment of measured values to absolute times not being possible. For such cases, it may therefore be advantageous to block or prevent adjusting the clock of the device or the time counter.
For more precise and informative history monitoring of a diabetes treatment and optimization of the treatment on the basis of a precise diagnosis, it is necessary to consider not only the data stored in the blood glucose measuring device, but also to register the insulin doses administered by the dosing device precisely and compare them to the measured values. It is also important to be able to optimize the therapy on the basis of an analysis. For this reason, the dosing devices used in the corresponding systems also have a memory apparatus for storing data.
Therefore, this requirement results in the analysis of the data from the dosing device and the blood glucose measuring device to allow a time registration of both the history data stored in the dosing device and blood glucose measuring device and also to assign the data registered by the dosing device and the blood glucose measuring device to one another in regard to time, i.e., to synchronize them in regard to time. Accordingly, this compensates for errors and deviations in the time registration and allows the data to be analyzed using the same correct timescale. This effort should be kept as simple as possible.
A system having a dosing device, a blood glucose measuring device, and a computer for displaying history data, as well as a communication adapter connecting the dosing device and the blood glucose measuring device to the computer, is known from EP 1 762 955. Both the dosing device and the blood glucose measuring device have a time standard, i.e., a clock, and the storage of a data set in the devices includes the associated clock time. On one hand, this requires more effort, and also the problem of time synchronization and assignment of history data is not solved for the case of unavoidably occurring deviations between the clocks in the two devices. The history data received by the computer and/or the communication adapter is unchanged and without time adjustment.
An infusion pump is disclosed in EP 1 115 435, which may be connected to a computer to read data. The clock times in the infusion pump and the computer are compared, and if a deviation occurs, the user is requested to reset the time in the clock. (See ¶ [0039]). The clock in the infusion pump is implemented by a counter which starts when the device is produced and is set to an absolute time. (See ¶ [0110]). The current clock time of the insulin pump then results from the start time and the number of count pulses passed since then. A corresponding implementation of an integrated time standard in a portable electrocardiogram recorder is described in U.S. Pat. No. 4,653,022.
A portable, independent ambulantly operable blood glucose measuring device for determining the blood glucose content of a sample of body fluid is disclosed in document DE 197 33 445 and U.S. Pat. No. 6,216,096. The device comprises an integrated time counter for generating relative time values, a memory unit in which data sets of blood glucose measurements and associated time values are stored, and a device for transmitting stored data sets to a data processing apparatus.
Document WO 2005/043306 describes a time synchronization system in an apparatus for emergency monitoring, in which all system components comprise an integrated time standard, i.e., a clock. This document teaches the synchronization of different medical devices used in emergency medicine, such as physiological monitors and defibrillators, each of which comprise a separate integrated time standard. These devices used in emergency medicine are typically large and costly such that an integration of a precise clock or a comfortable, clearly arranged operating unit is not considered a significant cost. In contrast, in a blood glucose system for treating a glucose metabolic disorder, both costs and size play a significant role. In addition, the devices of a blood glucose system to which the invention is directed are not operated by trained qualified personnel, as with emergency-medicine devices, but rather by laypersons who cannot be expected to operate complex devices, in particular because diabetes patients are frequently restricted in their manual capabilities.